FDA Registration Active 🇺🇸 United States

Genetic variant detection and health risk assessment system

Reg #: 3007699459 · FEI: 3007699459 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1

Registration Details

Registration Name
23ANDME, INC.
Registration Number
3007699459
FEI Number
3007699459
Status
Active
Expiry Year
2025
Initial Importer
No
Address
223 N Mathilda Ave
City
Sunnyvale
State
CA
ZIP
94086
Country
US

Regulatory Submissions

510(k) Number
DEN160026

Owner / Operator

Firm Name
23andMe, Inc.
Operator Number
10029404
Address
223 N. Mathilda Ave.
City
Sunnyvale
State
CA
Postal Code
94086
Country
US
Correspondent
Mark Pisaro

Products

Device Name Product Code
Genetic Variant Detection And Health Risk Assessment System PTA

Proprietary Names

Genetic variant detection and health risk assessment system

Establishment Types

Manufacture Medical Device